FDA recall D-0656-2024
ProRx LLC · Class II · drug
Product
TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
Reason for recall
Lack of Assurance of Sterility
Distribution
Nationwide in the USA
Key facts
- Status
- Ongoing
- Initiation date
- 2024-08-22
- Report date
- 2024-09-11
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Exton, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0656-2024